Dataset Information

Randomised controlled trial of neurostimulation for symptoms of anorexia nervosa (TRENA study): study protocol.

ABSTRACT:

Background

Anorexia nervosa (AN) has amongst the highest mortality rates and the highest treatment costs of any psychiatric disorder. Recently, interest in non-invasive brain stimulation as a novel treatment for AN has grown. These include repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS).

Methods

This double-blind, randomised sham-controlled trial will compare the relative acceptability and efficacy of tDCS and rTMS in people with AN. 70 participants will be randomised to active or sham tDCS, or active or sham rTMS treatment (2:1:2:1 ratio) over an 8-week treatment period. Participants will receive treatment as usual across the study duration. The primary outcomes are change on the Eating Disorder Examination Questionnaire and treatment acceptability. Secondary outcomes will include change in weight, cognition, mood, interpersonal functioning, and quality of life. Following the 8-week assessment, all participants will have the option of receiving an additional 12 weeks of at-home tDCS. A follow-up assessment will be conducted at 20 weeks post treatment.

Discussion

Research into non-invasive brain stimulation as treatments for AN has potential to improve clinical outcomes for patients by comparing the relative efficacy and acceptability of both treatment modalities in the inpatient and at-home setting (i.e., for at-home tDCS) results from this study will provide important information for informing future larger clinical trials of these treatments for AN.

Trial registration

ClinicalTrials.gov Identifier: NCT05788042.

SUBMITTER: Harvey AJ

PROVIDER: S-EPMC10709845 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature

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Publications

Randomised controlled trial of neurostimulation for symptoms of anorexia nervosa (TRENA study): study protocol.

Harvey Anna J AJ Madden Sloane S Rodgers Anthony A Bull Michael M Chatterton Mary Lou ML Hadzi-Pavlovic Dusan D Loo Colleen K CK Martin Donel M DM

Journal of eating disorders 20231208 1

<h4>Background</h4>Anorexia nervosa (AN) has amongst the highest mortality rates and the highest treatment costs of any psychiatric disorder. Recently, interest in non-invasive brain stimulation as a novel treatment for AN has grown. These include repetitive transcranial magnetic stimulation (rTMS) and transcranial direct current stimulation (tDCS).<h4>Methods</h4>This double-blind, randomised sham-controlled trial will compare the relative acceptability and efficacy of tDCS and rTMS in people w ...[more]

PMID: 38066658

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Project description:BackgroundAlthough preventive interventions for eating disorders in general have shown promise, interventions specifically targeting individuals at risk for anorexia nervosa (AN) are lacking.ObjectiveThe aim of this study was to determine the efficacy of a guided, indicated web-based prevention program for women at risk for AN.MethodsWe conducted a randomized controlled efficacy trial for women at risk for AN. Assessments were carried out at baseline (before the intervention), after the intervention (10 weeks after baseline), and at 6- and 12-month follow-ups (FUs). A total of 168 women with low body weight (17.5 kg/m2≤BMI≤19 kg/m2) and high weight concerns or with normal body weight (19 kg/m2<BMI≤25 kg/m2), high weight concerns, and high restrained eating were recruited from 3 German universities as well as on the web and randomized to Student Bodies-AN (SB-AN; intervention group [IG]) or a wait-list control group (CG). The exclusion criteria were current Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-based full-syndrome eating disorders and serious medical or mental problems. The interventions were a cognitive-behavioral guided web-based prevention program (SB-AN) over 10 weeks (IG) and a wait-list CG. The primary outcomes were clinically significant changes in disordered eating attitudes and behaviors and change in BMI at 12-month FU in the group of participants who were underweight. The secondary outcomes were new onset of eating disorders, symptoms of disordered eating, and associated psychopathology.ResultsData were available for 81.5% (137/168) of the women after the intervention and for 69% (116/168) of the women at 12-month FU. At 12-month FU, the IG participants showed larger decreases in Eating Disorder Examination total scores (38/48, 79% vs 33/58, 57%) than the CG participants and the IG participants who were underweight also showed larger clinically relevant increases in BMI (15/31, 49% vs 10/32, 32%) than the CG participants, but these differences were not significant. In addition, after the intervention and at 12-month FU, we found a significant increase in continuously measured BMI for the participants who were underweight and significant improvements in disordered eating attitudes and behaviors (eg, restrained eating as well as weight and shape concerns). At all time points, the rates of new-onset eating disorder cases were (nonsignificantly) lower in the IG than in the CG and the reductions in Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition-based eating disorder syndromes were (nonsignificantly) higher in the IG than in the CG.ConclusionsSB-AN is the first preventive intervention shown to significantly reduce specific risk factors for, and symptoms of, AN and shows promise for reducing full-syndrome AN onset.Trial registrationISRCTN Registry ISRCTN70380261; https://www.isrctn.com/ISRCTN70380261.

Project description:BackgroundAnorexia nervosa (AN) is associated with morbid fear of fatness, extreme food restriction and altered self-regulation. Neuroimaging data implicate fronto-striatal circuitry, including the dorsolateral prefrontal cortex (DLPFC).MethodsIn this double-blind parallel group study, we investigated the effects of one session of sham-controlled high-frequency repetitive transcranial magnetic stimulation (rTMS) to the left DLPFC (l-DLPFC) in 60 individuals with AN. A food exposure task was administered before and after the procedure to elicit AN-related symptoms.OutcomesThe primary outcome measure was 'core AN symptoms', a variable which combined several subjective AN-related experiences. The effects of rTMS on other measures of psychopathology (e.g. mood), temporal discounting (TD; intertemporal choice behaviour) and on salivary cortisol concentrations were also investigated. Safety, tolerability and acceptability were assessed.ResultsFourty-nine participants completed the study. Whilst there were no interaction effects of rTMS on core AN symptoms, there was a trend for group differences (p = 0.056): after controlling for pre-rTMS scores, individuals who received real rTMS had reduced symptoms post-rTMS and at 24-hour follow-up, relative to those who received sham stimulation. Other psychopathology was not altered differentially following real/sham rTMS. In relation to TD, there was an interaction trend (p = 0.060): real versus sham rTMS resulted in reduced rates of TD (more reflective choice behaviour). Salivary cortisol concentrations were unchanged by stimulation. rTMS was safe, well-tolerated and was considered an acceptable intervention.ConclusionsThis study provides modest evidence that rTMS to the l-DLPFC transiently reduces core symptoms of AN and encourages prudent decision making. Importantly, individuals with AN considered rTMS to be a viable treatment option. These findings require replication in multiple-session studies to evaluate therapeutic efficacy.Trial registrationwww.Controlled-Trials.com ISRCTN22851337.

Project description:IntroductionMulti-family therapy (MFT) is a recommended treatment for adolescent anorexia nervosa internationally. Despite recent significant advances in single-family therapy, the evidence base for MFT remains relatively small. Several individual and family factors have been associated with poorer outcomes in single-family therapy, many of which may be addressed or ameliorated by MFT if delivered early in treatment. This trial aims to determine the feasibility and acceptability of adding a five-day multi-family therapy group to the early stages of family therapy for anorexia nervosa. Secondary objectives are to explore effect size changes in key individual and family factors across treatment.MethodsThis feasibility trial will use a randomised controlled design. Sixty adolescents (age 10-17 inclusive) with anorexia nervosa or atypical anorexia nervosa and their parents will be recruited from a community-based specialist eating disorder service in London, UK. Participants will be randomly allocated to receive six months of eating disorder focussed family therapy with a five-day MFT group (experimental group) or without (control group). Block randomisation will be conducted by the King's Clinical Trials Unit and researchers will be blind to participants' intervention allocation. Feasibility, acceptability and secondary outcomes measures will be collected at baseline, post-MFT, end of treatment, six-month and 12-month follow-up. Feasibility and acceptability will be assessed according to trial sign-up rates, retention, measure completion rates and satisfaction. Secondary outcomes include physical health improvements, changes in psychiatric symptoms, emotion regulation and reflective function capacity, expressed emotion, parental difficulties and therapeutic alliance. Descriptive data and exploration analysis of trends and effect sizes will be reported upon at trial completion.DiscussionThe five-day MFT program developed for this study is novel, brief and more accessible than previous MFT models. The inclusion of a data collection point during treatment and follow-up will allow for an investigation of trends during and after treatment. This will allow exploration and comparison of future potential mediators and moderators of MFT and FT-AN outcomes and how these may differ between treatments.Trial registrationISRCTN registry; ISRCTN93437752 , on 27 January 2021.

Project description:BackgroundIn children with early-onset anorexia nervosa (first symptoms before 13 years old, EO-AN), experts recommend initial outpatient treatment but in-patient treatment (IP) is frequently indicated due to acute medical instability or for those who have not improved with outpatient treatment. This IP can target either a partial weight restauration or a total weight normalization (return to the previous BMI growth trajectory). There are no evidence in the literature on which is the better therapeutic option in EOAN. But as long length of stay induce social isolation, with elevated costs, we wonder if a stepped-care model of daypatient treatment (DP) after short IP stabilisation may be a treatment option as effective as full-time IP to target weight normalization. We designed a two-arm randomised controlled trial testing the non-inferiority of a stepped-care model of DP after short IP stabilisation versus full-time IP.MethodsEighty-eight children aged 8 to 13 years suffering from EOAN with initial severe undernutrition will be randomly allocated to either IP treatment as usual or a stepped care DP model both targeting weight normalization. Assessments will be conducted at inclusion, somatic stabilization, weight normalization, 6 months and 12 months post randomisation. The primary outcome will be BMI at 12 months post-randomisation. Secondaries outcomes will included clinical (tanner stage), biological (prealbumin, leptin, total ghrelin and IGF1) and radiological (bone mineralization and maturation) outcomes, eating symptomatology and psychiatric assessments, motivation to change, treatment acceptability and quality of life assessments, cost-utility and cost-effectiveness analyses.DiscussionCOTIDEA will provide rigorous evaluation of treatment alternative to full-time inpatient treatment to allow a reduction of social iatrogenic link to hospital length of stay and associated costs.Trial registrationTrial is registered on ClinicalTrials.gov (NCT04479683).

Project description:BackgroundAnorexia nervosa (AN) mainly affects women (sex ratio 1/10) and most often starts during adolescence. The prognosis of AN remains poor (10% of deaths and high risk of chronicity). Body dissatisfaction, disturbances in recognition and identification of body sensations are some of the key symptoms of AN. However, there is a contrast between this consensual observation of body image disorders in AN, and the relative deficit of specifically targeted body treatments. Our proposal for a body approach specifically dedicated to AN is based on the understanding that posture, breathing, muscle tension and body perception are closely linked to our psychological and emotional state and are therefore disturbed in patients with AN. The purpose of this monocentric randomized controlled trial is to evaluate if a targeted osteopathic protocol treatment for AN in addition to treatment as usual (TAU) is significantly more effective than TAU alone.MethodsIn total, 72 patients meeting the inclusion criteria will be randomly assigned to one of the two treatment groups: one receiving the specific osteopathic treatment targeted for AN in addition to the TAU (group A) and the other one, receiving TAU only (group B). The patients in group A will receive 5 30-min osteopathic treatment sessions. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be performed. The TAU is defined by the multidisciplinary approach recommended by the French health high authority. The primary outcome is the evaluation of interoceptive sensibility and secondary outcomes include clinical and psychopathology-related symptoms with assessment of somatic dysfunctions' evolution. A qualitative study will also be carried out, applying the Interpretative Phenomenological Analysis method. Patients will be included for a maximum of 14 weeks between the inclusion time and the last evaluation.DiscussionIf the results of the study are positive (statistically significant efficacy of this osteopathic treatment protocol), the study will provide arguments in favor of osteopathic sessions as a possible non-invasive additional treatment option in the multidisciplinary care approach for patients with AN.Trial registrationClinicalTrials.gov ID: NCT04666415 , Release Date: December 11, 2020; N° ID-RCB: 2019-A02613-54.

Project description:IntroductionProviding effective nutritional rehabilitation to patients hospitalised with anorexia nervosa (AN) is challenging, partly due to conservative recommendations that advocate feeding patients at low energy intakes. An 'underfeeding syndrome' can develop when patients are not provided with adequate nutrition during treatment, whereby malnourished patients fail to restore weight in a timely matter, and even lose weight. Of particular concern, the reintroduction of carbohydrate in a starved patient can increase the risk of developing electrolyte, metabolic and organ dysfunction. The proposed trial assesses the efficacy and safety of a lower carbohydrate enteral formula (28% carbohydrate) against a standard enteral formula (54% carbohydrate), in adolescent and young adult patients (aged 15-25 years), hospitalised with AN.Methods and analysisThe study employs a double-blind randomised controlled trial design. At admission to hospital, malnourished adolescent and young adults with AN will be randomly allocated to commence feeding on a standard enteral feeding formula (1.5 kcal/mL, 54% carbohydrate) or a lower carbohydrate isocaloric enteral feeding formula (1.5 kcal/mL, 28% carbohydrate). Assessments of nutritional intake, weight and biochemistry (phosphate, magnesium, potassium) will be conducted at baseline and during the first 3 weeks of hospital admission. The primary outcome measure will be incidence of hypophosphatemia. Secondary outcomes include weight gain, oedema, other electrolyte distortion, length of hospital admission, admission to the Intensive Care Unit (ICU) and number of days to reach medical stability, using defined parameters.Ethics and disseminationThe protocol was approved by the Western Sydney Local Health District Human Research Ethics Committee and institutional research governance approvals were granted. Written informed consent will be sought prior to study enrolment. Study findings will be widely disseminated through peer-reviewed publications and conference presentations.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617000342314); Pre-results.

Dataset Information

Randomised controlled trial of neurostimulation for symptoms of anorexia nervosa (TRENA study): study protocol.

Background

Methods

Discussion

Trial registration

Publications

Randomised controlled trial of neurostimulation for symptoms of anorexia nervosa (TRENA study): study protocol.

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